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Classification: 42000000 [ADJ215002]
|Preferred name||42 体外诊断技术|
|Definition||In-vitro diagnostic includes each medical device that is used as a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, separately or in combination with the others, intended by the manufacturer to be used for the in-vitro examination of samples derived from the human body, including blood and tissue donations, and that serves solely or principally for the purpose of providing information. The information provides knowledge on physiological or pathological conditions or congenital anomalies or serves for the testing on safety and compatibility with potential recipients, or for monitoring therapeutic measures|